Positioning and detaching implants

ABSTRACT

Intravascular implant systems and methods of positioning and detaching implants are described. One such system carries an implant by retaining an engagement member in a position proximal to an aperture at a distal end of the delivery system. The engagement member is retained proximal to the aperture by an elongate member that is coupled to the implant. Once the implant is in a desired implant position, the elongate member is released from the engagement member, and the implant is allowed to move away from the delivery system.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.13/308,476, filed Nov. 30, 2011, the disclosure of which is incorporatedherein by reference in its entirety.

TECHNICAL FIELD

The subject technology relates to therapeutic implant delivery systemsand, more particularly, to a system that positions, deploys, anddetaches an implant at a target location inside a body.

BACKGROUND

Sometimes a body cavity, such as an aneurysm, is located in a surgicallyremote and delicate region, such as within the tortuous cerebralvasculature, that requires a specialized delivery system to navigate tothe region and safely and reliably deliver and deploy an implant.

SUMMARY

Medical implants are important for their therapeutic and/or interveningroles in patients suffering from various ailments. For example, inferiorvena cava filters may be implanted into the inferior vena cava toprevent fatal pulmonary emboli. Dilation balloons may be used duringangioplasty procedures in order to widen the vessel and providestructural support.

While there are many known implant detach mechanisms such aselectrolytic separation, hydraulic delivery, and interference wire,these systems and methods often suffer from some reliability (e.g.,false positive detachments) and/or performance issues (e.g., rigidprofiles that are difficult to push).

Therefore, there is a need to provide alternative implant deliverysystems and methods that are reliable and overcome existing performanceissues.

Although at least some embodiments are described herein with respect toembolic coils, the subject technology may be used to position anddeliver a wide variety of medical devices, such as stents, filters,dilation balloons, thrombectomy devices, atherectomy devices, flowrestoration devices, embolic coils, embolic protection devices, or otherdevices to sites within the body.

In clinical situations it may be desirable to occlude blood vessels forvarious reasons, such as the control or prevention of bleeding, theprevention of blood supply to tumors, treatment of arterial venousmalformations (AVMs), and the blocking of blood flow within an aneurysm.Embolization of blood vessels has been performed by employing certainpolymer compositions, particulates, and/or sclerosing material includingsilicone balloons, metallic coils, PVA particles, gelatin, alcohol, andthe like, selectively to block blood flow in the blood vessels.

Intracranial aneurysms are abnormal blood-filled dilations of a bloodvessel wall that may rupture, causing significant bleeding and damage tosurrounding brain tissue or death. In some cases, intracranial aneurysmscan be surgically clipped to reduce the risk of rupture by placing ametal clip around the neck of the aneurysm to cut off and preventfurther blood flow to the aneurysm. Many aneurysms cannot be treatedsurgically because of either the location and configuration of theaneurysm or because the condition of the patient does not permitintracranial surgery.

Aneurysms may also be treated endovascularly, e.g., with embolic coils.The coils are placed in the aneurysm by extending a catheterendovascularly to the site of the aneurysm and passing single or oftenmultiple metallic coils such as platinum, stainless steel, or tungstencoils through the catheter into the aneurysm. The coils placed withinthe aneurysm cause a thrombus to form in the vicinity of the coil whichoccludes the aneurysm and prevents further blood flow to the aneurysm.The treatment of intracranial aneurysms with coils isolates the aneurysmfrom arterial circulation, helping to guard against rupture and furthergrowth of the aneurysm.

The subject technology is illustrated, for example, according to variousaspects described below. Various examples of aspects of the subjecttechnology are described as embodiments. These are provided as examplesand do not limit the subject technology. It is noted that theseembodiments may be combined in any combination.

In some embodiments, an assembly for deploying an implant into ananeurysm, comprises: a tubular member having (a) a member lumen in thetubular member and (b) an opening at a distal end portion of the tubularmember; a coil implant configured for placement into an aneurysm andhaving (a) a coil; (b) a coil lumen extending longitudinally within thecoil; and (c) a securing member (i) extending within the coil lumen,(ii) coupled, at a distal region of the securing member, to the coil,and (iii) having an enlarged proximal portion larger than, andpositioned distal to, the opening; and an elongate member extending inthe member lumen, through the opening, and coupled to the enlargedportion; wherein proximal movement of the elongate member relative tothe distal end portion results in the enlarged portion contacting thedistal end portion and separating from the elongate member.

In some embodiments, the enlarged portion is substantially spherical.

In some embodiments, the separating of the enlarged portion from theelongate member occurs at a location within the enlarged portion. Insome embodiments, the separating comprises breaking the elongate member.In certain embodiments, the separating comprises breaking the elongatemember at the location.

In some embodiments, the assembly further comprises a stop element,coupled to the elongate member and residing in the member lumen, thestop element contacting the distal end portion upon distal movement ofthe elongate member relative to the tubular member. In certainembodiments, the stop element is larger than the opening. In certainembodiments, the stop element is substantially spherical.

Some embodiments provide a frictional coupling between the elongatemember and the enlarged portion. In some embodiments, separation betweenthe elongate member and the enlarged portion occurs when a force appliedto the elongate member during the proximal movement exceeds a forcemaintaining the frictional coupling. In some embodiments, the separatingcomprises sliding the elongate member out of the enlarged portion. Incertain embodiments, the sliding comprises sliding the elongate memberout of an aperture in the enlarged portion

In some embodiments, the elongate member extends distally beyond theenlarged portion. In some embodiments, the elongate member extendsthrough the enlarged portion. In certain embodiments, the elongatemember, distal to the enlarged portion, has an undulating profile. Incertain embodiments, the elongate member, distal to the enlargedportion, has a profile having a pattern of peaks. In certainembodiments, the elongate member, distal to the enlarged portion,extends helically.

In some embodiments, the elongate member has (i) a frictional couplingwith the enlarged portion and (ii) an undulating profile distal to theenlarged portion. In some embodiments, the elongate member, distal tothe enlarged portion, comprises a shape memory material.

In some embodiments, the separating occurs when a force of the proximalmovement exceeds both (a) a force maintaining the frictional couplingand (b) a force required to change the undulating profile as theelongate member is drawn proximally past the enlarged portion.

In some embodiments, the enlarged portion comprises a proximal coilportion having a proximal lumen, and the elongate member extends throughthe proximal lumen. In certain embodiments, the coil portion is crimpedon the elongate member, forming a frictional coupling between the coilportion and the elongate member. In certain embodiments, the separatingoccurs when a force applied to the elongate member during the proximalmovement exceeds a force maintaining the frictional coupling.

Some embodiments provide a method for deploying an implant into ananeurysm, comprising: advancing in a patient's vasculature: (i) atubular member comprising (a) a member lumen in the tubular member and(b) an opening at a distal end portion of the tubular member; (ii) acoil implant configured for placement into an aneurysm and comprising(a) a coil; (b) a coil lumen extending longitudinally within the coil;and (c) a securing member (i) extending within the coil lumen, (ii)coupled, at a distal region of the securing member, to the coil, and(iii) having an enlarged proximal portion larger than, and positioneddistal to, the opening; and (iii) an elongate member extending in themember lumen, through the opening, and coupled to the enlarged portion;and withdrawing the elongate member proximally relative to the tubularmember, to release the coil at an aneurysm, the enlarged portion thereby(i) contacting the end portion and (ii) separating from the elongatemember.

In some embodiments, the separating of the enlarged portion from theelongate member occurs at a location within the enlarged portion. Incertain embodiments, the separation of the enlarged portion and theelongate member comprises breaking the elongate member. In certainembodiments, the step of separating comprises breaking the elongatemember within the enlarged portion. In some embodiments, the separatingstep occurs when a force applied to the elongate member during theproximal movement exceeds a force maintaining a frictional couplingbetween the elongate member and the enlarged portion. In certainembodiments, the separating step in some methods comprises pulling theelongate member from within the enlarged portion. In certainembodiments, the separating step comprises withdrawing a distal segmentof the elongate member through the enlarged portion, the segment havinga curved profile. In certain embodiments, the curved profile comprises awave profile.

Some embodiments provide a method, of forming an attachment coupling ofan implant assembly, comprising: plastically deforming a proximalportion of a coil implant, implantable in an aneurysm onto an elongatemember to create a friction coupling between the proximal portion andthe elongate member; wherein the proximal portion is positioned distalto an opening at a distal end portion of a tubular member through whichthe elongate member extends.

In certain embodiments, the deforming comprises crimping. In certainembodiments, the deforming comprises swaging.

Some embodiments provide a method, of forming an attachment coupling ofan implant assembly, comprising: forming a joint between a proximalportion of a coil implant, implantable in an aneurysm, and an elongatemember; wherein a tensile strength of the joint is less than (a) atensile strength of the proximal portion and (b) a tensile strength ofthe elongate member; wherein the coupling proximal portion is positioneddistal to an opening at a distal end portion of a tubular member throughwhich the elongate member extends.

In certain embodiments, the forming comprises welding. In certainembodiments, the forming comprises soldering.

Some embodiments provide an assembly for deploying an implant into ananeurysmal space in a vessel in a patient's body, comprising: a tubularmember having (a) a member lumen in the tubular member and (b) anopening at a distal end portion of the tubular member; a coil implanthaving an enlarged portion positioned in the member lumen proximal tothe opening; and an elongate member extending in the lumen, the elongatemember having a distal segment that extends, in the member lumen, pastpart of the enlarged portion and contacts a distal-facing surface of theenlarged portion, thereby retaining the enlarged portion in the memberlumen; wherein proximal movement of the elongate member relative to theend portion results in deformation of the distal segment to release theenlarged portion from the member lumen.

In certain embodiments, the enlarged portion is substantially spherical.In certain embodiments, the segment extends around part of the enlargedportion. In certain embodiments, the opening is sized to prevent passageof the distal segment through the opening.

In some embodiments, the coil implant comprises a coil having a lumenand a securing member (i) extending within the coil lumen, (ii) coupled,at a distal region of the securing member, to the coil, and (iii)coupled, at a proximal region of the securing member, to the enlargedportion. In certain embodiments, the releasing occurs as the distalsegment slides between the enlarged portion and the tubular member. Incertain embodiments, the distal segment extends around opposed surfacesof the enlarged portion. In certain embodiments, the distal segmentforms a socket that receives the enlarged portion.

In some embodiments, the assembly further comprises a stop element,coupled to the securing member and residing distal to the opening, thestop element contacting the distal end portion upon proximal movement ofthe elongate member relative to the tubular member. In certainembodiments, the stop element is larger than the opening. In certainembodiments, the stop element comprises a coil. In certain embodiments,the stop element is substantially spherical.

In some embodiments, the releasing occurs by the distal segmentpivoting, within the lumen, about the enlarged portion. In certainembodiments, the pivoting results in the distal segment losing contactwith the distal-facing surface. In certain embodiments, the releasingoccurs by the distal segment tilting within the lumen.

In some embodiments, the distal segment comprises a slot that receives,within the lumen, a portion of the coil implant distal to the enlargedportion. In certain embodiments, the distal segment covers substantiallythe entire distal-facing surface.

In some embodiments, the coil implant comprises a coil having a lumenand a securing member (i) extending within the coil lumen, (ii) coupled,at a distal region of the securing member, to the coil, and (iii)coupled, at a proximal region of the securing member, to the enlargedportion; and the distal segment comprises a slot that receives, withinthe lumen, a portion of the securing member.

In certain embodiments, the distal segment covers substantially theentire distal-facing surface.

Some embodiments provide a method for deploying an implant into ananeurysm, comprising: positioning in a patient's vasculature: (i) atubular member having (a) a member lumen in the tubular member and (b)an opening at a distal end portion of the tubular member; (ii) a coilimplant having an enlarged portion positioned in the member lumenproximal to the opening; and (iii) an elongate member extending in thelumen, the elongate member having a distal segment that extends pastpart of the enlarged portion, in the member lumen, and contacts adistal-facing surface of the enlarged portion, thereby retaining theenlarged portion in the member lumen; and moving the elongate memberproximally relative to the tubular member to deform the distal segment,thereby releasing the enlarged portion from the member lumen.

Some embodiments provide a system for placing an implant in an aneurysm,comprising: a tubular member having (a) a member lumen in the tubularmember and (b) an opening at a distal end portion of the tubular member;a coil implant configured for placement in an aneurysm and having anenlarged portion positioned in the member lumen proximal to the opening;and a elongate member extending in the lumen and having an expandablebody (a) positioned at least partially distal to the enlarged portion inthe lumen and (b) expandable distal to the enlarged portion to retainthe enlarged portion in the lumen.

In certain embodiments, the expandable body comprises a mesh. In certainembodiments, the expandable body comprises a balloon.

In some embodiments, a proximal movement of the elongate member relativeto the tubular member, the body compresses and moves past the enlargedportion, thereby releasing the coil implant from the tubular member. Incertain embodiments, the enlarged portion is substantially spherical.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andclaims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology asclaimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this specification, illustrate aspects of thesubject technology and together with the description serve to explainthe principles of the subject technology.

FIG. 1A shows a plan view of the positioning system in accordance withsome embodiments of the subject technology, and a plan view of anexemplary implant in accordance with some embodiments of the subjecttechnology.

FIG. 1B shows a closer view of a portion of FIG. 1A.

FIG. 2A shows a plan view of the position system of FIG. 1A within thehuman body.

FIG. 2B shows a closer view of a portion of FIG. 2A showing thepositioning system in partial cross-section and an exemplary implant inaccordance with some embodiments of the subject technology in a positionwithin the human body.

FIG. 2C shows a closer view of a portion of FIG. 2A showing thepositioning system in partial cross-section and an exemplary implant inaccordance with some embodiments of the subject technology in anotherposition within the human body.

FIG. 3 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 4 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 5 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 6 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 7 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 8 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 9A shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 9B shows an end view of a component of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 10 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 11 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 12 shows a closer view of a portion of an exemplary implantinterface in accordance with some embodiments of the subject technology.

FIG. 13A shows a closer view of a portion of an exemplary implant inaccordance with some embodiments of the subject technology.

FIG. 13B shows a cross-section view of an exemplary implant inaccordance with some embodiments of the subject technology.

FIG. 14 shows a closer view of a portion of an exemplary implant inaccordance with some embodiments of the subject technology.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. It willbe apparent, however, to one ordinarily skilled in the art that thesubject technology may be practiced without some of these specificdetails. In other instances, well-known structures and techniques havenot been shown in detail so as not to obscure the subject technology.

A phrase such as “an aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples of the disclosure. A phrasesuch as “an aspect” may refer to one or more aspects and vice versa. Aphrase such as “an embodiment” does not imply that such embodiment isessential to the subject technology or that such embodiment applies toall configurations of the subject technology. A disclosure relating toan embodiment may apply to all embodiments, or one or more embodiments.An embodiment may provide one or more examples of the disclosure. Aphrase such “an embodiment” may refer to one or more embodiments andvice versa. A phrase such as “a configuration” does not imply that suchconfiguration is essential to the subject technology or that suchconfiguration applies to all configurations of the subject technology. Adisclosure relating to a configuration may apply to all configurations,or one or more configurations. A configuration may provide one or moreexamples of the disclosure. A phrase such as “a configuration” may referto one or more configurations and vice versa.

While the preferred embodiments of the subject technology relate tovasculature implant systems and means of deploying an implant in avasculature, the systems and methods of this disclosure may generally beused for or in conjunction with any systems or methods that arecompatible with mechanical detachment mechanisms as described herein.

A vascular implant device may be a positioning system 10 such as oneshown in FIGS. 1A-1B. The positioning system 10 shown in FIGS. 1A-1Bincludes an actuator 20, a positioner 40 coupled with the actuator 20,and an implant interface 80 at the distal end of the positioner 40. Aportion of the implant interface 80 may engage a complementary portionof an implant 100 in order to control the delivery (i.e., securing anddetaching) of the implant 100 at the desired location. While the implantis shown or described in several embodiments as comprising an emboliccoil 90, any implant (e.g., stents, filters, dilation balloons,thrombectomy devices, atherectomy devices, flow restoration devices,embolic coils, embolic protection devices, etc.) that is compatible withthe subject technology may be used in accordance with the embodimentsdescribed herein.

FIG. 2A shows the positioning system 10 of FIGS. 1A-1B used inside apatient's vasculature. In the embodiment shown in FIG. 2A, an operatoruses a guide tube or guide catheter 12 to position a delivery tube ormicrocatheter 14 in a patient's vasculature. This procedure involvesinserting the guide catheter 12 into the patient's vasculature throughan access point such as the groin, and directing the distal end 12 a ofthe guide catheter 12 through the vascular system until it reaches thecarotid artery. After removing a guide wire (not shown) from the guidecatheter 12, a microcatheter 14 may be inserted into the guide catheter12 and the distal end 14 a of the microcatheter 14 subsequently exitsthe guide catheter distal end 12 a and may be positioned near the targetsite 16, such as an aneurysm in the patient's brain.

In the embodiments illustrated in FIGS. 2B and 2C, the microcatheter 14also includes microcatheter markers 15 and 15 a that facilitate imagingof the distal end 14 a of the microcatheter 14 with common imagingsystems. After the distal end 14 a reaches the target site 16, thepositioning system 10 of the illustrated embodiment is then insertedinto the microcatheter 14 to position the implant interface 80 at thedistal end of the positioner 40 near the target site 16, as illustratedin FIG. 2C. The implant 100 can be attached to the implant interface 80prior to inserting the positioning system 10 into the microcatheter 14.This mode of implant delivery is illustrated in FIGS. 2A-2C. Thedelivery of the implant 100 is facilitated by disposing themicrocatheter marker 15 a near the target site 16, and aligning themicrocatheter marker 15 with a positioner marker 64 in the positioner 40which, when the two markers (markers 15 and 64) are aligned with eachother as illustrated in FIG. 2C, indicates to the operator that theimplant interface 80 is in the proper position for the release of theimplant 100 from the positioning system 10.

Referring to FIGS. 1A-1B, the implant interface 80 is a portion of thepositioning system 10 that allows the operator to mechanically controlthe engagement and disengagement of the implant 100 to the positioner40, and allows the positioner 40 to retain the implant 100 in a way thatminimally contacts the implant 100, that permits movement of the implantrelative to the positioner in some or all of axial, tilt, and rotationaldirections, and that in some embodiments allows the implant 100 to moveaxially and without radial movement when engaging and disengaging theimplant interface 80.

The implant interface 80 provides mechanical control of the engagementand disengagement of the implant 100 by retaining a member engaging theimplant 100. In some embodiments, this member is a securing member 94that is coupled at its proximal end to the distal tip 88 of an elongatemember 52 such as shown in FIGS. 3-4. The securing member 94 is alsocoupled to a structure such as embolic coil 90 at its distal portion. Inthe embodiment shown in FIGS. 3-4, the elongate member 52 is disposed inthe cavity 86 that is defined by the distal surface 72 of the stopper70, the proximal surface 83 of the end cap 82, and the inner walls ofthe positioner tube 42. A positioner tube sleeve 66 encloses thepositioner tube 42 to provide a sliding exterior surface to thepositioner tube 42 that facilitates the insertion and sliding of thepositioner tube 42 into and through the microcatheter 14 (FIGS. 2A-2C).The distal end of the cavity 86 terminates at an end cap 82 which has aport 84 for communicating with the distal exterior environment. Theimplant interface 80 may also include an enlarged portion 96 and a stopelement 85.

An implant may be any implant that can be retained and positioned by apositioning system (e.g., a catheter delivery system). Suitable examplesof implants include, but are not limited to, stents, filters, dilationballoons, thrombectomy devices, atherectomy devices, flow restorationdevices, embolic coils, embolic protection devices, etc.

Referring to the embodiments shown in FIGS. 3-4, the implant 100 isdepicted with the coil 90 being retained by the implant interface 80 byan extension (e.g., securing member 94) that engages or is coupled tothe coil 90. The extension can be a part of the implant 100 when theimplant 100 is made, a modified portion of the manufactured implant 100,or attached to the implant 100 after initial manufacturing.

In the embodiments illustrated in FIGS. 1A-1B, 2B-9A, 10-13A, and 14,the implant 100 is depicted as comprising an embolic coil 90. FIGS.1A-1B shows the coil 90 in a coiled orientation prior to insertion intothe microcatheter 14. For simplicity, the implant 100 shown in FIGS.2B-9A, 10-13A, and 14 is in a truncated form and disposed in alignmentwith the axis and the interior of the microcatheter (not shown). Theimplant 100 shown in FIG. 2C is shown in an implanted state, disposed inan aneurysm.

Referring to FIG. 14, the implant 100 may comprise (i) a coil 90 havinga proximal portion and a distal portion; (ii) a stretch-resistant member112 extending through the coil 90 and having a proximal end and a distalend, the stretch-resistant member 112 distal end coupled to the coil 90distal portion; (iii) a reduced dimension proximal portion which may bea crimped portion 116 of a coil shell 118 disposed at the proximal endof the stretch-resistant member 112, and which can be otherwise free ofthe proximal portion of the coil 90. In some embodiments, the crimpedportion 116 may be welded to the proximal portion of the coil 90.

In particular, the crimped portion 116, with a reduced dimension, andthe coil 90 may be free to rotate around the central axis of the implant100 as facilitated by the illustrated embodiments. As shown in FIG. 14,the distal portion of the stretch-resistant member 112 extends throughthe coil lumen 105 defined by the coil 90 and is coupled to coil 90 atthe distal end (e.g., by a polymer melt 114), which allows the coil 90have free rotation about a longitudinal axis. In some existing systems,the implant or a portion of the implant may be firmly held by thedelivery system and is not free to rotate and, when the implant anddelivery system are advanced distally to the target site through amicrocatheter, the surface of the implant (especially the helicalsurface of some coils) can induce a torque within the implant when movedalong the lumen of a microcatheter. That torque is stored as a potentialenergy in a compressed spring within the implant itself and within theconnection between the implant and the delivery system. When the implant100 then emerges from the microcatheter 14 at the target site, it isbelieved that the potential energy can be released suddenly and causethe implant to twist unpredictably and deposit itself in an undesirablelocation.

The positioning system 10 facilitates the unhindered rotation of thecrimped portion 116 and coil 90, thereby avoiding this problem thatexists with some delivery systems. The free rotation of the coil 90 andcrimped portion 116 allows the implant 100 to be deployed from themicrocatheter 14 at the target site 16 much more gently than with somesystems having a connection that is rigid or that partly or whollylimits movement and rotation between the implant and delivery system,and the free rotation also lowers the force applied to the vasculatureduring deployment and positioning of the implant 100 at the target site16.

Commercially available embolic coils suitable for use with thepositioning system 10 include the Sapphire™, Axium™, NXT™, and Nexus™embolic coils, commercially available from EV3, Inc. of Plymouth, Minn.USA. Although the implant 100 of the illustrated embodiment comprises anembolic coil, the implant 100 may be any implant that can be insertedwith a catheter, such as a stent, a filter, a dilation balloon, athrombectomy device, an atherectomy device, a flow restoration device,an embolic coil, or an embolic protection device.

Commercially available stents suitable for use with the delivery system10 include the IntraStent®, ParaMount™, PRIMUS™, PROTÉGÉ®, andSolitaire™ stents, commercially available from EV3, Inc. of Plymouth,Minn. USA.

A commercially available embolic protection device suitable for use withthe delivery system 10 is the SpideRX® embolic protection device,commercially available from EV3, Inc. of Plymouth, Minn. USA.

While aspects of an exemplary positioner are described herein, anypositioner that is compatible with the subject technology may be used inconjunction with this disclosure. The positioner 40 provides theoperator the ability to move the implant 100 controllably through themicrocatheter 14 and to position the implant properly at the target site16. The positioner 40 provides a mechanical system for selectivelyengaging the implant 100, while maintaining a narrow profile andsufficient flexibility to navigate the tortuous pathways within the bodyto reach the target site 16. While providing a small and flexibleprofile, the positioner 40 has sufficient strength to allow the operatorto controllably move the implant 100 through the microcatheter 14, andthe mechanical engagement with the implant 100 remains functional andcontrollable when subjected to high tortuosity near the target site 16.

The mechanical engagement of the positioner 40 to the implant 100 alsomaintains the proper orientation of the implant 100 throughout thepositioning procedure by allowing the implant 100 to rotate anddischarge any torsional forces induced during the movement of theimplant 100 to the target site 16. The positioner 40 also allows theoperator to control the movement of the positioner 40 and implant 100 byproperly translating the control exerted by the operator intopredictable and responsive movements near the target site 16.

While aspects of an exemplary actuator and actuator interface aredescribed herein, any actuator and/or actuator interface that iscompatible with the subject technology may be used in conjunction withthis disclosure. The actuator interface 80 provides the operator theability to control the movement of the implant 100 as it is positionedby the positioning system 10, and to mechanically control the selectiveengagement and disengagement of the implant 100 and implant interface80. The actuator interface 80 controls the movement of the implant 100by providing a surface upon which the operator can exert control, sothat the controlling motions of the operator are accurately transferredto the implant interface 80 and implant 100 through the positioner 40.

The actuator 20 provides a mechanism that removably engages the actuatorinterface 80 and causes the controllable and predictable movement of theactuator interface 80. The actuator 20 also provides a design thatallows the operator to hold the actuator 20 firmly in place, in order tomaintain the position of the positioner 40 relative to the target site16, and allows the operator to utilize the actuator 20 in a controlledmanner that minimizes the movement of the positioner 40.

The proximal portion (e.g., enlarged portion 96, etc.) of the implant100 is generally designed to be complementary to the distal portion(e.g., end cap 82, port 84, etc.) of the tubular member (e.g.,positioner tube 42, catheter, etc.). Prior to the delivery of theimplant 100 to the target site 16, the implant 100 may be coupled,either directly or indirectly, to the implant interface 80. FIGS. 3-14show closer views of various exemplary embodiments of the implantinterface 80 and mechanisms for detaching the implant 100 from theimplant interface 80. While the various exemplary embodiments includethe delivery of coil implants, any compatible implants may be used inaccordance with the embodiments described herein.

FIGS. 3-14 show various exemplary assemblies for deploying an implant100 in a vasculature. In some embodiments, the assembly may include atubular member (e.g., position tube 42) defining a member lumen (e.g.,cavity 86) within the tubular member and further defining an opening(e.g., port 84) at the distal portion (e.g., end cap 82) of the tubularmember. One or more of the assemblies may further include an implant 100extending distally from the positioner tube 42 and an elongate member 52moveably disposed within the positioner tube 42.

In some embodiments, the implant 100 is configured for placement into ananeurysm or other treatment site within a patient. In some embodiments,the implant 100 may include an embolic coil 90 formed by a wire,filament, or other elongate member helically-wrapped about a centralaxis to form a generally tubular structure. As shown in FIG. 14, thecoil 90 may define a lumen 105 therein which extends axially along thelength of the coil 90. The implant 100 may further include an enlargedportion 96 coupled to or otherwise forming an integral part of thesecuring member 94, which extends into the lumen 105 and is coupled toor otherwise forms an integral part of the implant 100 (e.g., coil 90).The coil 90 may be coupled to the distal region of the securing member94, which extends through the coil lumen 105. In some embodiments, theenlarged portion 96 may be positioned within the cavity 86 proximal tothe opening (e.g., port 84). In certain embodiments, however, theenlarged portion 96 may be positioned outside the cavity 86, asillustrated, distal to the opening. In some embodiments, the enlargedportion 96 may be larger than the opening. In some embodiments, theenlarged portion 96 may be smaller than the opening.

In some embodiments, the elongate member 52 extends within the tubularmember lumen. In some embodiments, the elongate member 52 extendsdistally through the port 84. In some embodiments, the elongate member52 may be coupled to the enlarged portion 96. In some embodiments, theelongate member 52 has a distal segment 88 that extends past theenlarged portion 96. In some embodiments, the elongate member 52contacts the distal-facing surface 130 (FIG. 7-10) of the enlargedportion 96 thereby retaining the enlarged portion 96. In someembodiments, the elongate member 52 has an expandable body 140 (FIG.12). In some embodiments, the expandable body 140 may be expandeddistally to the enlarged portion 96 thereby retaining the enlargedportion 96. In some embodiments, the elongate member 52 is positioned atleast partially distal to the enlarged portion 96.

FIGS. 3-5, 7-10, 12, and 14 relate to embodiments that detach or releasethe implant 100 through a proximal motion of the elongate member 52.This proximal motion may be achieved by, for example, pulling proximallyon the elongate member 52 with respect to the tubular member or pushingon the tubular member such that the tubular member moves distally withrespect to the elongate member 52 or both.

FIGS. 6 and 11 relate to embodiments that detach or release the implant100 by a distal translation of the elongate member 52. This distaltranslation may be achieved by, for example, pushing the distal portion88 of the elongate member 52 such that elongate member 52 moves distallywith respect to the tubular member or pulling on the tubular member suchthat the tubular member moves proximally with respect to the elongatemember 52 or both.

In the embodiments shown in FIGS. 3-4, the implant interface 80 includesa cavity 86 defined at least in part by a tubular member, a positionertube 42, an end cap 82, a stopper 70, an elongate member 52 and itsdistal portion 88, a positioner tube sleeve 66, and a stop element 85.

In particular, the positioner tube 42, the end cap 82, and the distalfacing wall 72 of the stopper 70 define a cavity 86 within the implantinterface 80. The stopper 70 can function to guide and control themovement of the distal portion 88 of the elongate member 52.

In some embodiments, the positioner tube 42 is made from a material thatis flexible and strong enough to transfer forces applied by the operator(e.g., a surgeon) at the proximal end to the implant interface 80.Suitable examples of materials include, but are not limited to, 304stainless steel hypotube, polymeric extrusion, braided extrusion, orengineering polymer materials (e.g., polyether ether ketones (PEEK),polyimide, nylon, polyester, etc.) that can have about 0.010 to about0.018 inch outer diameter and about 0.005 to about 0.012 inch innerdiameter, with about 10 to about 60 cm length of the distal end of thepositioner tube 42 ground to about 0.008 to about 0.016 inch outerdiameter to reduce girth and increase flexibility. The positioner tube42 may be comprised of slots, holes, laser cuts, or other structures toprovide flexibility to portions of or all of the positioner tube 42. Aswill be appreciated, the dimensions and/or materials of the positionertube 42 may vary without departing from the scope of the disclosure.

In some embodiments, the end cap 82 is made of about 0.001 to about0.005 inch thick 304 stainless steel, a polymeric material, or a steelalloy retainer ring with about 0.008 to about 0.018 inch outer diameterand about 0.003 to about 0.009 inch diameter port welded or bonded tothe distal end of the positioner tube 42. As will be appreciated, thedimensions and/or materials of the end cap 82 may vary without departingfrom the scope of the disclosure.

In some embodiments, the stopper 70 is made of 304 stainless steel, aplatinum alloy, a polymeric extrusion, a braided extrusion, or anon-elongating polymeric material with about 0.001 to about 0.012 inchinner diameter, and is coupled (e.g., welded or glued) to the interiorof the positioner tube 42. The dimensions and/or materials of thestopper 70 may also vary, without departing from the scope of thedisclosure.

In some embodiments, the elongate member 52 is a cord, a wire, a rod, atubular, a thread or a filament made of a metal or a polymer. Thecross-section of the elongate member 52 may be circular. In certainembodiments, however, the cross-section may be other shapes, such aspolygonal, without departing from the scope of the disclosure. In someembodiments, the elongate member 52 has an outer diameter from about0.001 to about 0.005 inch, but the outer diameter may vary, depending onthe application.

As shown in FIGS. 3-4, the positioner tube sleeve 66 may encase orgenerally surround the longitudinal length of the positioner tube 42,thereby providing a sliding engagement between the positioner tube 42and the positioner tube sleeve 66. The sliding engagement may facilitatethe insertion and sliding of the positioner tube 42 into and through themicrocatheter 14 (FIGS. 2A-2C). In operation, the positioner tube sleeve66 may be configured to increase the lubricity between the positionertube 42 and the inner lumen surface of the microcatheter 14 and tofurther increase the structural integrity of the positioner tube 42. Ascan be appreciated, it is particularly advantageous to reduce frictionbetween the positioner tube 42 and the microcatheter 14 at the distalone third of the positioning system 10 as this distal-most portion issubject to tortuous anatomy that causes additional friction betweenmoving components.

As illustrated in FIGS. 3-5, the enlarged portion 96 may be coupled tothe proximal end of the securing member 94, which is attached to thecoil 90 at the proximal end of the coil 90 and positioned distal to theport 84. In the embodiments shown in FIGS. 3-5, the enlarged portion 96has a cross-sectional area that is greater than a cross-sectional areaof the port 84, which prevents the enlarged portion 96 from passingtherethrough, and thereby prevents the coil 90 from coming into contactwith the end cap 82. A stop member 85 may also be disposed within thecavity 86 and coupled to or otherwise formed integrally with theelongate member 52. The stop element 85 also has a cross-sectional areathat is greater than the cross-sectional area of the port 84. Thus, thestop member 85 and the enlarged portion 96 limit the range of axialmotion possible for the implant 100 to traverse while engaged at theimplant interface 80, which in turn may be advantageous for greateraccuracy and faster positioning of the implant 100 in the target site 16(FIG. 2A). In these embodiments, the implant interface 80 and theimplant 100 may be directly coupled to the elongate member 52 so thatany longitudinal translation of the elongate member 52 corresponds to asimilar or same translation of the securing member 94.

The implant 100 shown in FIG. 3 may be detached from the positioningsystem 10 according to at least the following embodiments. According toone or more embodiments, a proximal motion of the elongate member 52 cancause the enlarged portion 96 to come in contact with the end cap 82.This proximal motion can be achieved by any number of ways includingpulling of the elongate member 52 away from the target site or pushingof the positioner tube 42 towards the target site or a combination ofboth. In some embodiments, the proximal motion is caused by an actuatorpositioned at the proximal portion of the positioning system 10. Alongitudinal force applied proximally along the axis of the elongatemember 52 can contribute to the release or the detachment of the implant100. Given sufficient force, the securing member 94 can break so as todetachably release the implant 100 from the positioning system 10. Insome embodiments, given sufficient force, at least one of the enlargedportion 96, securing member 94, and the elongate member 52 can break soas to detachably release the implant 100.

It is generally desirable to controllably break at least one of thesecuring member 94 and the elongate member 52 so that the break islocalized to a relatively small portion along the securing member 94 orthe elongate member 52. In some embodiments, the breakage occurs at astructurally weak spot such as, but not limited to, an etched, crimped,reduced diameter, annealed, or notched spot. In some embodiments, atleast one of the securing member 94 and the elongate member 52 is madefrom a frangible material so that it tends to break up into, forexample, two pieces rather than deforming plastically and retaining itscohesion as a single object. Examples of suitable frangible materialsinclude, but not limited to, aluminum oxide, silicon dioxide, magnesiumoxide, zirconia, cordierite, silicon carbide and the like. In someembodiments, the proximal portion of the elongate member and/or securingmember 94 is frangible so that any breaking is localized to thoseportions. In some embodiments, at least one of the securing member 94and the elongate member 52 may be configured to break inside theenlarged portion 96. In some embodiments, the distal portion 88 ofelongate member 52 may break to release the implant 100. In someembodiments, the enlarged portion 96 may break to release the implant100. In some embodiments, the stop element 85 may break to release theimplant 100.

In some embodiments, the surfaces at or near the proximal portion of thesecuring member 94 and/or inner walls defined by a recess 125 of theenlarged portion 96 may have a topography that enhances frictionalcontact. The recess 125 is generally designed to receive andfrictionally engage the securing member 94 through contact. In someembodiments, the securing member 94 and inner walls of the enlargedportion 96 may have periodic gratings that provide frictional contactwith each other. In some embodiments, the inner walls of the enlargedportion 96 and/or the distal portion of the securing member 94 may bemade from a material that has a relatively high frictional coefficientor have surfaces that are coarse. Examples of suitable materialsinclude, but are not limited to, silicone rubber, acrylic rubbercoatings, steel, cast iron, zinc, platinum, tungsten, etc. In someembodiments securing member 94, elongate member 52, or both may besecured to the enlarged portion 96 by compressing the enlarged portion96 onto the securing member 94 and the elongate member 52. This may beaccomplished by swaging, crimping, pressing, casting the enlargedportion 96 onto the securing member 94 and elongate member 52, byadhering enlarged portion 96 onto the securing member 94 and elongatemember 52, or by other means.

In the embodiment shown in FIG. 4, the elongate member 52 extendsdistally through the port 84 and terminates outside the port 84. Thesecuring member 94 is coupled to the distal portion 88 of the elongatemember 52 through frictional contact with the enlarged portion 96. Asshown in FIG. 4, the proximal end of the securing member 94 is disposedin the enlarged portion 96 and making frictional contact with innerwalls of the recess 125 within the enlarged portion 96.

In the embodiment shown, a proximal motion of the elongate member 52will cause the enlarged portion 96 to come in contact with the end cap82. In some embodiments, a proximal force will cause the distal portion88 of the elongate member 52 to disengage from the enlarged portion 96.In some embodiments, the proximal force causes the distal portion 88 ofthe elongate member 52 to disengage from the stop element 85. Althoughless likely, in certain embodiments, when a force applied proximally onthe enlarged portion 96 is greater than the frictional force between thesecuring member 94 and the enlarged portion 96, the securing member 94will disengage from the enlarged portion 96 and thereby detach theimplant 100 from the positioning system 10.

In the embodiment shown in FIG. 5, the proximal portion of the securingmember 94 may be engaged with the enlarged portion 96 that is coupled toan elongate member 52 that is at least partially disposed within thecavity 86 and extends distally through the port 84. As shown in FIG. 5,an obstructed portion 150 of elongate member 52 extends distally pastthe enlarged portion 96. This curved profile of the obstructed portion150 increases the detach force required for the release of the implant100 as compared to a non-undulating profile. In some embodiments, thecurved profile may be any shape that obstructs the release of the curvedportion 150. Suitable shapes include, but are not limited to, crimpedshape, S-shape, O-shape, and the like. In some embodiments, the curvedprofile may have multiple peaks or an undulating profile (e.g.,sinusoidal shape, helical, etc.).

A proximal motion of the elongate member 52 may cause the enlargedportion 96 to engage the end cap 82. If the force applied proximally onthe elongated member 52 is greater than the detach force, the crimpedportion 150 of the elongated member 52 will at least partiallystraighten and release from the enlarged portion 96, thereby detachingthe implant 100 from the positioning system 10. In some embodiments, thecrimped portion 150 of the elongated member 52 will be released from theenlarged portion 96 by sliding through an aperture in the enlargedportion 96.

In the embodiment shown in FIG. 6, the proximal portion of the securingmember 94 is coupled to the stop element 85 and the enlarged portion 96.As shown in FIG. 6, the enlarged portion 96 is disposed in the cavity 86proximal to the port 84 while the stop element 85 is positioned distalto the port 84 and proximal to the coil 90. This embodiment alsoincludes a pusher 160 that is part of the distal portion 88 of theelongate member 52. The enlarged portion 96 has a cross-section that isgenerally larger than the cross-section of the port 84 so that theenlarged portion 96 is prevented or hindered from passing through theport 84.

In some embodiments, the end cap 82 may be a retaining ring that is madefrom a radially expandable material. Generally, any radially expandablematerial that is compatible with one or more embodiments may be used.Suitable examples of expandable materials may include, but are notlimited to, silicone, thermoplastic elastomers, rubbers, metals,nickel-titanium alloys, polymers (e.g., polytetrafluoroethylene (PTFE),polyethylene terephthalate (PET), polyether ether ketones (PEEK)), etc.The pusher 160 may generally be used to apply a longitudinal force thatcauses a distal motion of the enlarged portion 96. This longitudinalforce can cause the enlarged portion 96 to come into contact with theradially expandable end cap 82. Given a sufficient force, the enlargedportion 96 can engage the end cap 82 to forcibly expand the end cap 82and allow the enlarged portion 96 to pass through port 84.

In certain embodiments, the enlarged portion 96 may be made from adeformable material. Given a sufficient longitudinal force that actsdistally, the enlarged portion 96 can deform while engaging the end cap82 to allow the enlarged portion 96 to pass through. In general, anydeformable material that is compatible with one or more embodiments maybe used. Suitable examples of deformable materials may include, but arenot limited to, silicone, thermoplastic elastomers, biopolymers,rubbers, metals, nickel titanium alloys, etc.

In the embodiments shown in FIGS. 7-10, the enlarged portion 96 isdisposed in the positioner tube 42 and coupled to a distal segment 88 ofthe elongated member 52 that at least partially extends around theenlarged portion 96. In some embodiments, the coupling between theenlarged portion 96 and distal portion 88 of the elongate member 52 maybe achieved through a ball and socket connection (FIG. 7-8), a ball anda curved wire connection (FIG. 9A-9B), a pivot and cam (FIG. 10), ahinge joint, a pivot joint, and the like.

In the embodiments shown in FIGS. 7-8, the enlarged portion 96, whichcan be a ball, is disposed in the positioner tube 42 while positionedproximal to the port 84 and coupled to the proximal portion of thesecuring member 94. In the embodiment shown in FIG. 7, a stop element 85is positioned distal to the port 84 and proximal to the coil 90. Whilethe enlarged portion 96 is generally small enough to fit or pass throughport 84, the stop element 85 is generally large enough to abut the port84 when drawn proximally. The socket element 170 is coupled to thedistal portion 88 of the elongated member 52 and disposed in thepositioner tube 42. As shown in FIGS. 7-8, the socket element 170 isconfigured to at least partially envelope or contact the distal facingsurface 130 of the enlarged portion 96, which at least partially helpsto retain the enlarged portion 96.

In some embodiments, the socket element 170 may further include at leastone spring loaded element (e.g., a leaf) that promotes release of theenlarged portion 96 upon a proximal pulling motion on the socket element170. In some embodiments, the proximal pulling motion may cause anelastic or plastic deformation of the socket element 170, which allowsthe release of the enlarged portion 96. The socket element 170 maygenerally be made from any material that is compatible with one or moreembodiments. Suitable materials include, but are not limited to, alloys(e.g., nickel-titanium, titanium-palladium-nickel, Elgiloy, stainlesssteel, nickel-iron-zinc-aluminium, bronze, platinum alloys, titaniumalloys, etc.), thermoplastics, metals (platinum, titanium, etc.),ceramics, etc. In some embodiments, the socket element 170 may include apartially spherical recess defined by the socket and a slot (not shown)that extends through a portion of the recess. In some embodiments, theenlarged portion 96 may be coupled to the socket element 170 by pivotingthe elongated member 52, securing member 94, or both so that thesecuring member 94 may slide into the slot while the enlarged portion 96is disposed inside the partially spherical recess. Once the enlargedportion 96 is secured inside the recess, the ball and socket connectionmay be straightened out so as to keep a narrow profile during insertioninto a positioner tube 42.

In the embodiment shown in FIGS. 9A-9B, the enlarged portion 96 isdisposed in the positioner tube 42 and coupled to a curved wire 180positioned at a distal segment 88 of the elongated member 52. As shownin FIG. 9A, the distal end of the positioner tube includes an opening240 that is larger than the enlarged portion 96. The curved wire 180partially extends around distal facing surface 130 of the enlargedportion 96 to retain the enlarged portion 96 within the positioner tube42. FIG. 9B shows an end view of the curved wire 180, which shows a slot75 that runs transversely and is designed to receive a securing member94. The curved wire 180 may generally be made from any material that iscompatible with one or more embodiments. Suitable examples of materialsinclude, but are not limited to, alloys (e.g., nickel-titanium,titanium-palladium-nickel, Elgiloy, stainless steel,nickel-iron-zinc-aluminium, bronze, platinum alloys, titanium alloys,etc.) and metals (platinum, titanium, etc.).

Referring to FIGS. 9A-9B, the ball element 96 may be coupled to thecurved wire element 180 by pivoting the elongated member 52, securingmember 94, or both so that the securing member 94 may slide into theslot 75 while the ball element 96 is disposed inside the concavecurvature defined by the curved wire 180. Once the ball element 96 issecured inside the concave curvature, the ball 96 and curved wire 180connection may be straightened out as to keep a narrow profile duringinsertion into a positioner tube 42. In some embodiments, the curvedwire 180 may extend distal to the opening 240 while the securing member94 is positioned in the slot 75 and the enlarged portion 96 is retainedby the concave curvature of the curved wire 180. A proximal motion ofthe elongate member 52 would draw the retained assembly into thepositioner tube 42.

In some embodiments, the implant 100 may be released by plastically orelastically deforming the curved wire 180. Such deformations may beachieved by pulling the elongate member 52 proximally with a sufficientforce such that coil 90 abuts positioner tube 42, which allows thecurved wire 180 to straighten as it is drawn proximally past theenlarged portion 96. Optionally, the elongate member 94 may include astop (not shown) similar to a stop element 85, which is placed proximalto the coil 90 and distal to the opening 240. The stop may be larger insize than the opening 240 and is able to abut edges of the opening 240when the curved wire 180 is drawn proximally.

In the embodiment shown in FIG. 10, the enlarged portion 96 is disposedin the positioner tube 42 and positioned proximal to the port 84. Insome embodiments, the enlarged portion 96 may be small enough to fitthrough port 84 or port 84 may be substantially same diameter of lumenof positioner tube 42. In the embodiment shown in FIG. 10, the enlargedportion 96 is attached to the proximal portion of the securing member 94and further coupled to a pivot 190 and cam 200 element that is part ofthe distal portion of the elongated member 52. The elongated member 52and the cam 200 are coupled at the rotatable pivot 190. The cam element200 may be hemi-spherical or otherwise designed to partially receive theenlarged portion 96 therein. The cam element 200 and the pivot 190 maygenerally be made from any material that is compatible with one or moreembodiments described herein. Suitable materials include, but are notlimited to, alloys (e.g., nickel-titanium, titanium-palladium-nickel,Elgiloy, stainless steel, nickel-iron-zinc-aluminium, bronze, platinumalloys, titanium alloys, etc.), thermoplastics, metals (platinum,titanium, etc.), ceramics, etc.

In the engaged configuration shown in FIG. 10, the cam 200 is positionedso that a portion of its concave surface is engaging the distal facingsurface of the enlarged portion 96. This allows the cam to retain theenlarged portion 96 within the positioner tube 42 as needed. In someembodiments, the cam 200 may further include a slot (not shown) forreceiving and retaining the securing member 94.

In the embodiment shown in FIG. 10, the port 84 is larger than theenlarged portion 96 so that the enlarged portion 96 is able to passthrough the port 84 once the pivot cam releases the enlarged portion 96.In some embodiments, the enlarged portion 96 is released from the cam200 by drawing the elongate member 52 proximally until coil 90 contactsthe end cap 82. Further proximal movement of the elongate member 52causes the cam 200 to rotate about pivot 190, thereby disengaging theconcave surface of the cam 200 from the distal surface of the enlargedportion 96 and freeing the enlarged portion 96 to travel distally thruthe cavity 86 and out of the port 84. In certain embodiments, the port84 is made from an expandable material and is smaller than the enlargedportion 96, as described above with respect to FIG. 6, and the enlargedportion 96 passes through the smaller dimensioned port 84 by applying aforce sufficient to expand the port 84.

In the embodiment shown in FIG. 11, the enlarged portion 96 extendsthrough the opening 240 and is disposed in the positioner tube 42. Inthe embodiment shown, the opening 240 is larger than the enlargedportion 96. FIG. 11 shows a pre-detachment configuration in which theenlarged portion 96 is locked in place on one side by the edges of anaperture 115 (side window) defined in the wall of the positioner tube42. An elastomeric padding 220 contacts the side of the enlarged portion96 that is opposed to the aperture 115. The elastomeric padding 220 maygenerally be made from any material that is compatible with one or moreembodiments. Suitable examples of materials include, but are not limitedto, silicone, thermoplastic elastomers, rubbers, polymers (e.g.,polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET),polyether ether ketones (PEEK)), etc.

The distal portion of the elongated member 52 comprises pusher 160,which is configured to engage the enlarged portion 96 by distal movementof the elongated member 52. A ramp 230 may also be disposed inside thepositioner tube 42 and acts to guide the pusher 160 to engage theenlarged portion 96 during the detachment of the implant 100. In someembodiments, the implant 100 may be detached by pushing the pusher 160against the enlarged portion 96, thereby causing the enlarged portion 96to move distally within the positioner tube 42, compressing theelastomeric padding 220, and forcing the enlarged portion 96 distallyout of the side window 115 and further distally out of the opening 240.

In the embodiment shown in FIG. 12, the enlarged portion 96 extendsthrough the opening 240 and is disposed in the positioner tube 42. Inthe embodiment shown, the opening 240 is larger than the enlargedportion 96. FIG. 12 shows a pre-detachment configuration in which theenlarged portion 96 is coupled to the distal portion (compressed mesh260) of the elongated member 52. The compressed mesh may be anexpandable/compressible material that deformably locks the enlargedportion 96 inside the positioner tube 42 and proximal to the opening240. Suitable examples of materials include, but are not limited to,woven or knitted metal wires comprised of, for example, Nitinol,stainless steel, Elgiloy, platinum alloys, titanium alloys, or othermetals. The woven or knitted materials may also be comprised of, forexample, polymers such as polypropene, polyethylene, polyethyleneterephthalate (PET), or other materials. Additionally, the mesh 260 canbe a foam comprised of, for example, polymers such as silicone,polypropylene, polyethylene, nylon, etc. or an elastomeric solidcomprised of silicone rubber, butyl rubber, polyurethane, or othermaterials. At least a portion of the enlarged portion 96 is in contactwith a wall within the cavity 86, and at least a portion of compressedmesh is in contact with a wall within the cavity 86 and engages adistally facing surface of the enlarged portion 96.

In some embodiments, the implant 100 may be detached by pulling theelongate member 52 proximally, causing the compressed mesh 260 to moveproximally in relation to the enlarged portion 96, and drawing the coil90 against the opening 240. In some embodiments, the coil 90 is largerthan the opening 240, limiting further proximal movement of the coil 90.In some embodiments, the more distal portions of the compressed mesh 260become compressed as the compressed mesh 260 is drawn proximally pastthe enlarged portion 96. Once the compressed mesh 260 is entirelyproximal to the enlarged portion 96, the enlarged portion 96 may movedistally within the positioner tube 42 and out of the opening 240.

In the embodiment shown in FIG. 13A-13B, the implant 100 includes anenlarged portion 96 that may have fins or fin-like structures (e.g.,struts) that extend radially and transversely out from the central axisof the securing member 94. The fins or fin-like structures may generallybe made from any material that is compatible with one or moreembodiments of the subject technology. Suitable examples of materialsinclude, but are not limited to, alloys (e.g., nickel-titanium,titanium-palladium-nickel, bronze, Elgiloy, stainless steel, titaniumalloys, platinum alloys, etc.), metals (platinum, titanium, etc.),ceramics, etc. The fins or fin-like structures can also be comprised of,for example, polymers such as polypropene, polyethylene, polyethyleneterephthalate (PET), or other materials. Additionally, the fins can be afoam comprised of, for example, polymers such as silicone,polypropylene, polyethylene, and nylon or an elastomeric solid comprisedof silicone rubber, butyl rubber, polyurethane, or other materials.

The cross-section of the enlarged portion 96 may have any shape such as,for example, a star (FIG. 13B). The distal portion 250 of the enlargedportion 96 may also have a distal curvature (e.g., convexity or aconcavity, not shown). While not shown, this embodiment may interactwith an implant interface 80 such as shown in FIGS. 3-12. The enlargedportion 96 may be disposed in the positioner tube 42 through a port 84that is smaller than the enlarged portion.

In some embodiments, the cross-section of the port 84 of the end cap 82can be non-circular or have a shape that is complementary to theenlarged portion 96 (e.g., FIG. 13B). In these embodiments having acomplementary port 84 and enlarged portion 96, detachment of the implant100 may generally be accomplished by rotating the enlarged portion 96 tofit through the similarly shaped port 84 as by a “lock and key”mechanism.

In the embodiment shown in FIG. 14, the distal portion of the elongatemember 52 extends past the port 84 and is disposed inside the implantcoil lumen 105 where it is coupled to the coil lumen extending portion112 of the securing member via a straight release mechanism. In theembodiment shown, the distal portion of the elongate member 52 engagesan eyelet 110, or a portion thereof, that forms the proximal portion ofthe securing member 112. The distal portion of the elongate member 52preferably terminates proximal to the eyelet 110, the distal portionforming a straight member. The coil may be crimped about the straightmember to frictionally retain the straight member inside the coil shell116. In some embodiments, the coil is swaged or otherwise plasticallydeformed about the straight member. Further, as shown in FIG. 14, aportion of the coil shell that is just distal to the port 84 is crimpedaround the portion of the elongate member 52 that is just proximal tothe eyelet and just distal to the port 84. The crimped portion of thecoil shell is severed from the rest of the coil shell 118.

In some embodiments, the crimped portion of the coil shell 116 is weldedto the rest of the coil shell 118. In certain embodiments, the eyelet110 may be separate and distinct from the elongate member 52. In somecases, the elongate member 52 may be frictionally retained within lumenof crimped potion 116. Proximally drawing the elongate member 52liberates the elongate member 52 from lumen of the crimped portion 116.In certain embodiments, the eyelet 110 is attached or coupled to thecrimped portion 116 by, for example, welding, adhesives, friction, etc.Optionally, a stop element 85 may be added to the elongate member 52proximal to the port 84.

In some embodiments, the elongate member 52 is coupled to the eyelet 110by means of a line of weakness that separates when the elongate member52 is pulled proximally, using means similar to those embodiments shownand/or described for FIG. 3.

While FIGS. 3-14 disclose specific embodiments, some or all of thefeatures of the embodiments described herein may be used interchangeablyor in combination with each other or with other embodiments.

In some embodiments, methods for deploying an implant 100 are provided.Suitable implants include, but are not limited to, stents, filters,dilation balloons, thrombectomy devices, atherectomy devices, flowrestoration devices, embolic coils, embolic protection devices, or otherdevices, and the like. In some embodiments, the method includes:advancing in a vasculature, an assembly according to any of theembodiments described herein; and detaching the implant.

In some preferred embodiments, the assembly includes a tubular member(e.g., a catheter), a implant 100 configured for placement into ananeurysm, an enlarged portion 96, and an elongate member 52.

In some embodiments, the detachment of the implant 100 is achieved bywithdrawing the elongate member 52 proximally relative to the tubularmember, thereby separating the enlarged portion 96 from the elongatemember 52 at the enlarged portion 96, to release the coil 90 at ananeurysm.

In some embodiments, the separating occurs at a location within theenlarged portion 96. In some embodiments, the separating includesbreaking the elongate member 52. In some embodiments, the separatingincludes breaking the elongate member 52 within the enlarged portion. Insome embodiments, the separating includes pulling the elongate member 52from within the enlarged portion 96

In some embodiments, the separating occurs when a force applied to theelongate member 52 during the proximal movement exceeds a forcemaintaining a frictional coupling between the elongate member 52 and theenlarged portion 96. In some embodiments, the separating compriseswithdrawing a distal segment of the elongate member through the enlargedportion, the segment having a curved profile. In some embodiments, thecurved profile is a wave.

In some embodiments, the method includes: positioning in a vasculature,an assembly according to any of the embodiments described herein; anddetaching the implant.

In some preferred embodiments, the assembly includes a tubular member,an implant 100, an enlarged portion 96 positioned in the member lumenproximal to the opening, and an elongate member 52.

In some embodiments, the detachment of the implant 100 is achieved bymoving the elongate member 52 proximally relative to the tubular memberto deform a distal segment of the elongate member 52, thereby releasingthe enlarged portion 96 from the member lumen.

Referring to FIG. 3, the implant 100 may be detached from a tubularmember (e.g., positioning system 10) by pulling proximally alongitudinal member (e.g., an elongate member 52) that includes anenlarged portion 96 positioned outside the tubular member and a stopelement 85 positioned inside the tubular member, the longitudinal memberbeing coupled to the implant 100. The longitudinal member is pulledproximally with a force sufficient to break the member to release theimplant 100. In some embodiments, the implant 100 is detached by pushingthe tubular member (e.g., positioning system 10 or positioner 10)distally. The tubular member's distal end preferably contacts anenlarged portion 96 (coupled to the implant 100), and the tubular memberis pushed distally relative to the elongate member 52 with a forcesufficient to break the member, thereby releasing the implant 100. Theimplant 100 may also include a stop element 85 (positioned inside thetubular member) that limits distal advancement of the longitudinalmember as the stop element 85 contacts the end cap 82. In someembodiments, the stop element 85 on the longitudinal member absorbsforces (e.g., inadvertent longitudinal advancement or vibrations) thatmay be transferred to the implant 100 via the longitudinal member.

Referring to FIG. 4, the implant 100 may be detached from a tubularmember (e.g., positioning system 10) by (i) coupling a longitudinalmember that extends through a tubular member with an enlarged portion 96that is frictionally coupled to an implant 100 and (ii) pulling thelongitudinal member proximally with a force sufficient to overcome thefrictional coupling. In some embodiments, the implant 100 is detachedfrom a tubular member (e.g., positioning system 10) by pushing thetubular member relative to the longitudinal member or elongate member 52with a force sufficient to overcome the frictional coupling.

Referring to FIG. 5, the implant 100 may be detached from a frictionalcoupling between a longitudinal member and an enlarged portion 96 of theimplant 100 by pulling the longitudinal member proximally with a forcesufficient to overcome the frictional coupling. In some embodiments, theimplant 100 is detached from a tubular member (e.g., positioning system10) by pushing the tubular member relative to the longitudinal memberwith a force sufficient to overcome the obstruction. Generally, a forcesufficient to overcome the obstruction will conformationally change(e.g., straighten) the wavy or helical shape of the member extendingdistal to the enlarged portion 96. In some embodiments, the force issufficient to conformationally change the shape of the member andovercome any frictional coupling between the longitudinal member and theenlarged portion 96.

Referring to FIG. 6, the implant 100 may be detached from the tubularmember (e.g., positioning system 10) by using a pusher to apply a forcedistally on the enlarged portion 96 with a sufficient longitudinal forceso that the enlarged portion 96 may be pushed through the expandableretaining ring (e.g., end cap 82). Generally, the sufficientlongitudinal force will increase the cross-section of the port 84 topermit the enlarged portion 96 to pass therethrough.

Referring to FIG. 7-8, the implant 100 may be generally detached from atubular member (e.g., positioning system 10) by withdrawing in aproximal direction the ball and socket connection once the implant 100is ready to be deployed. The socket may be elastically or plasticallydeformed to allow the enlarged portion 96 to be withdrawn. Generally,the stop element or the coil will abut the distal end of the catheter tolimit proximal withdrawal and further withdrawal to cause the socket tochange shape, thus allowing the enlarged portion 96 to be released.

In those embodiments where the socket element 170 has a slot that helpsto retain the implant 100, the ball and socket connection may be pivotedas to allow the free release of the implant 100. In some embodiments,the enlarged portion 96 may be smaller than the port 84. In someembodiments, the enlarged portion 96 may be larger than the port 84,which is expandable. In order to release the enlarged portion 96 fromthe smaller dimensioned port 84, a force sufficient to expand the port84 as to allow the enlarged portion 96 to pass through is required.

Referring to FIGS. 9A-9B, the implant 100 may be detached from a tubularmember (e.g., positioning system 10) by pivoting the ball and curvedwire connection once the implant 100 is ready to be deployed. In theembodiment shown in FIG. 9A, the enlarged portion 96 has across-sectional size that is less than a cross-sectional area of theopening at the distal end of the tubular member. This allows theenlarged portion 96 to pass freely through the port 84 when the implant100 is disengaged. In some embodiments, the enlarged portion 96 may belarger than the opening, which is made of an expandable material. Inorder to release the enlarged portion 96 from the smaller dimensionedport 84, a force sufficient to expand the port 84 may be applied toallow the enlarged portion 96 to pass through.

Referring to FIG. 10, the implant 100 may be detached from a tubularmember (e.g., positioning system 10) by pulling proximally the elongatedmember 52 so that the cam 200 rotates about the pivot 190 to allow theenlarged portion 96 to release freely. In some embodiments, the cam 200elastically or plastically deforms to release the enlarged portion 96.

Referring to FIG. 11, the implant 100 may be detached by applying asufficient pushing force distally onto the enlarged portion 96 by thepusher 160 as to further deform elastomeric padding and allow theenlarged portion 96 to disengage from the aperture 115 and to advancepast the opening 240.

Referring to FIG. 12, the implant 100 may be detached from a tubularmember (e.g., positioning system 10) by pulling the elongated member 52proximally so that the distal portion of the elongated member 52 slidesagainst at least a portion of the enlarged portion 96. This slidingaction causes the distal portions of the compressed mesh 140 to deformas to allow the enlarged portion 96 to be released and pass through theopening 240.

Referring to the implant 100 embodiments shown in FIGS. 13A-13B, thesemay be used in conjunction with a suitable implant interface 80 such asshown in, for example, FIG. 3. The implant 100 may generally be detachedby applying a distal force sufficiently to the enlarged portion 96 (e.g.by a pusher shown in FIG. 6) such that the distal curvature 250 of theenlarged portion 96 may interact with end cap 82 and deform as to allowthe enlarged portion 96 to pass through the port 84.

The enlarged portion 96 may have a non-circular cross-section. The port84 may also have a non-circular cross-section that is complementary tothe cross-section of the enlarged-portion 96. In such cases, theenlarged portion 96 can be rotated (or the tubular member is rotated) sothat the enlarged portion 96 may fit through the port 84 to release theimplant 100.

Referring to FIG. 14, the implant 100 may be detached by pulling theelongate member 52 proximally at a sufficient force to overcome thefrictional resistance of the crimped connection thereby detaching theimplant 100.

Referring to FIG. 14, methods for forming an attachment coupling of animplant assembly are provided. In one embodiment, the method includesplastically deforming a proximal portion of a coil implant onto anelongate member to create a friction coupling between the proximalportion and the elongate member. The proximal portion is positioneddistal to an opening at a distal end portion of a tubular member throughwhich the elongate member extends. In some cases, the deforming isachieved by crimping or swaging.

Referring again to FIG. 14, in another embodiment, the method includesforming a joint between a proximal portion of a coil implant and anelongate member such that a tensile strength of the joint is less than atensile strength of the proximal portion and a tensile strength of theelongate member. The coupling proximal portion is preferably positioneddistal to an opening at a distal end portion of a tubular member throughwhich the elongate member extends. In some cases, the forming isachieved by welding or soldering.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.” Theterm “some” refers to one or more. Underlined and/or italicized headingsand subheadings are used for convenience only, do not limit the subjecttechnology, and are not referred to in connection with theinterpretation of the description of the subject technology. Allstructural and functional equivalents to the elements of the variousconfigurations described throughout this disclosure that are known orlater come to be known to those of ordinary skill in the art areexpressly incorporated herein by reference and intended to beencompassed by the subject technology. Moreover, nothing disclosedherein is intended to be dedicated to the public regardless of whethersuch disclosure is explicitly recited in the above description.

While certain aspects and embodiments of the invention have beendescribed, these have been presented by way of example only, and are notintended to limit the scope of the invention. Indeed, the novel methodsand systems described herein may be embodied in a variety of other formswithout departing from the spirit thereof. The accompanying claims andtheir equivalents are intended to cover such forms or modifications aswould fall within the scope and spirit of the invention.

I/We claim:
 1. A system for placing an implant at an aneurysm,comprising: a tubular member having (a) a member lumen in the tubularmember and (b) an opening at a distal end portion of the tubular member;an implant configured for placement at an aneurysm and having anenlarged portion positioned in the member lumen proximal to the opening;and an elongate member extending in the lumen and having anexpandable/compressible body (a) positioned at least partially distal tothe enlarged portion in the lumen and (b) expanded distal to theenlarged portion to retain the enlarged portion in the lumen.
 2. Thesystem of claim 1, wherein the expandable/compressible body comprises amesh.
 3. The system of claim 1, wherein the expandable/compressible bodycomprises a balloon.
 4. The system of claim 1, wherein upon proximalmovement of the elongate member relative to the tubular member, the bodycompresses and moves past the enlarged portion, thereby releasing theimplant from the tubular member.
 5. The system of claim 1, wherein theenlarged portion is substantially spherical.
 6. The system of claim 1,wherein the opening at the distal end portion of the tubular member islarger than the enlarged portion.
 7. The system of claim 1, wherein atleast a portion of the enlarged portion is in contact with the tubularmember, and at least a portion of expandable/compressible body is incontact with the tubular member and engages a distally facing surface ofthe enlarged portion.
 8. A system for placing an implant at an aneurysm,comprising: a tubular member having a member lumen and an opening at adistal end portion of the tubular member; an implant having an enlargedportion positioned in the lumen proximal to the opening; and an elongatemember extending in the lumen, the elongate member having anexpandable/compressible body that contacts a distal-facing surface ofthe enlarged portion, thereby retaining the enlarged portion in themember lumen, wherein proximal movement of the elongate member relativeto the end portion results in deformation of the expandable/compressiblebody to release the enlarged portion from the member lumen.
 9. Thesystem of claim 8, wherein the expandable/compressible body comprises amesh.
 10. The system of claim 8, wherein the expandable/compressiblebody comprises a balloon.
 11. The system of claim 8, wherein theenlarged portion is substantially spherical.
 12. The system of claim 8,wherein the opening at the distal end portion of the tubular member islarger than the enlarged portion.
 13. The system of claim 8, wherein atleast a portion of the enlarged portion is in contact with the tubularmember, and at least a portion of expandable/compressible body is incontact with the tubular member and engages the distal-facing surface ofthe enlarged portion.
 14. A method for deploying an implant at ananeurysm, comprising: advancing in a patient's vasculature: (i) atubular member comprising a member lumen and an opening at a distal endportion of the tubular member; (ii) an implant configured for placementat an aneurysm and having an enlarged portion positioned in the memberlumen proximal to the opening; (iii) an elongate member extending in thelumen and having an expandable/compressible body (a) positioned at leastpartially distal to the enlarged portion in the lumen, and (b) expandeddistal to the enlarged portion to retain the enlarged portion in thelumen; and withdrawing the elongate member proximally relative to thetubular member to release the coil at the aneurysm.
 15. The method ofclaim 14, wherein withdrawing the elongate member comprises withdrawingthe elongate member until the expandable/compressible body is positionedproximal to the enlarged portion.
 16. The method of claim 14, whereinwithdrawing the elongate member comprises deforming theexpandable/compressible body with the enlarged portion.
 17. The methodof claim 14, wherein the expandable/compressible body comprises a mesh.18. The method of claim 14, wherein the expandable/compressible bodycomprises a balloon.
 19. The method of claim 14, wherein withdrawing theelongate member comprises withdrawing the elongate member with a forcethat exceeds a force maintaining a frictional coupling between theexpandable/compressible body and the enlarged portion.
 20. The method ofclaim 14, wherein, after withdrawing the elongate member proximallyrelative to the tubular member, the enlarged portion of the coil passesthrough the opening at the distal end portion of the tubular member.